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BioLife Solutions CryoStor® AND HypoThermosol® Now Embedded In 130 Regenerative Medicine Clinical Trials

Clinical Grade Cell and Tissue Biopreservation Media Products Enabling Commercialization of Cellular Immunotherapies and Restorative Therapies

BOTHELL, Wash., Aug. 25, 2014 /PRNewswire/ -- BioLife Solutions, Inc. (NASDAQ:BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products for cells and tissues ("BioLife" or the "Company"), today provided an update on adoption of the Company's proprietary HypoThermosol and CryoStor biopreservation media products.  Management estimates that BioLife's products are now incorporated into the collection, storage, shipping, freezing, and/or patient administration processes of at least 130 customer clinical trials or novel cell-based regenerative medicine products and therapies.

Further details include:

  • More than a dozen phase III trials
  • More than 60 phase II trials
  • Most large patient population disease states are covered by the trials including various cancers, heart disease, vision loss, movement loss, stroke, and MS
  • Specific to cancer, BioLife has more than a dozen customers working to commercialize cell-based immunotherapies
  • Annual product revenue per clinical trial stage product, if approved and large scale commercial manufacturing commences, could be in the range of $500,000 to $2,000,000

Mike Rice, BioLife's President & CEO commented on broadening adoption of CryoStor and HypoThermosol by stating, "The pace of adoption of our clinical grade biopreservation media products has picked up nicely over the last few years. Less than two years ago in October 2012, we estimated that our products were being used in more than 50 customer clinical trials.  It's very satisfying to see our work to educate the regenerative medicine market pay off.  Our customers clearly see benefits of extending cell and tissue shelf life, improving yield, and increasing the quantity and quality of biologics following biopreservation. These benefits can be monetized and are positively impacting the cost structure of new regenerative medicine products." 

The November 2013 Visiongain Translational Regenerative Medicine market research report forecasts that the regenerative medicine market comprised of cell and gene therapies and tissue-engineered products will grow to more than $23 billion by 2024. BioLife's expects to participate in this market growth by providing biopreservation media and precision thermal packaging products used to store, freeze, ship, and administer clinical cells and tissues to patients. 

Rice continued, "As more progress has been made, development priorities in the market have evolved from cell characterization and potency assays, to manufacturing scale up/scale out, to the current focus on transportation and logistics.   We're very committed to helping our customers optimize delivery and administration of precious cells and tissues to patients and look forward to launching our biologistexSM cold chain management service later this year."

About BioLife Solutions

BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and precision thermal shipping products for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company's proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife's biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death.  BioLife's enabling technology provides commercial companies and clinical researchers significant improvement in shelf-life and post-preservation viability and function of cells, tissues, and organs.  For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

This press release contains forward-looking statements, including, but not limited to, statements concerning our potential revenue growth, market size and market expansion. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of our products; market volatility; competition; litigation; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

SOURCE BioLife Solutions, Inc.

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